A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors

A Phase Ib Study of hPV19, a Novel Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF),in Combination With Chemotherapy in Patients With Advanced Solid Tumors Refractory to Standard Therapy.

hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. In this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.

Inclusion Criteria:

• Confirmed malignity
• Measurable disease
• Performance status 2 or less(ECOG)
• Life expectancy ≥3 months

Exclusion Criteria:

• hepatitis C virus (HCV), or HIV antibody positive
• Previously received anti-VEGF mAb or fusion-protein drugs within 28 days nearly
• Evidence of serious infection